Increasing ("boosting") the radiation dose for patients with non-small cell lung carcinoma to the individual maximal dose which can safely be given. The question is if patients should receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized for one of these two treatment options. All patients will receive 24 radiations. Dose increasement will be enabled by a so called integrated boost.

Furthermore:

PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and four hours post injection.

Patients in this arm will receive radiotherapy (66Gy) in 24 fractions of 2.75 Gy with an integrated boost to the primary tumor as a whole

Radiation: Radiotherapy

Radiotherapy

Other Name: Radiotherapy

Boost 50% SUV area

Patients in this arm receive radiotherapy (66Gy) in 24 fractions of 2.75Gy with an integrated boost to the 50% SUVmax area of the primary tumor (of the pre-treatment FDG-PET-CT scan)

Radiation: Radiotherapy

Radiotherapy

Other Name: Radiotherapy

Detailed Description:

A randomized phase II study will be conducted in patients with inoperable stage IB, II or III non-small cell lung cancer (NSCLC). The patients will be randomized to receive the standard 66 Gy given in 24 fractions of 2.75 Gy with an integrated boost to the primary tumor as a whole (Arm A) or with an integrated boost to the 50% SUVmax area of the primary tumor (of the pre-treatment FDG-PET scan) (Arm B). Both treatment arms may be combined with chemotherapy (concurrent or sequential). Patients fulfilling the eligibility criteria will be registered in the study, and an initial radiotherapy treatment planning will be performed. When an integrated boost to the primary tumor as a whole up to 72 Gy is not possible because of dose constraints, the patient will receive 66 Gy or lower according to the normal tissue tolerance (see below). They will not be randomized, but will be followed in the trial. As such, it will be clear which proportion of patients can receive an integrated boost and what the outcome is when dose-escalation is not possible.

Stage IB-II patients receive radiotherapy alone, and stage III patients combined chemotherapy and radiation. The patients may have received induction chemotherapy up to two cycles before registration in this trial. The statistical calculations have been performed to deal with this patient heterogeneity.

The primary objective of this study is to determine the local progression-free survival (LPFS)at 1 year.

Secondary objectives will be

Toxicity as a function of radiotherapy dose and volume of the tissue irradiated.

Overall survival.

Quality of life

Furthermore:

PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and four hours post injection.

Dynamic Contrast-Enhanced CT imaging

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients > 18 years with any subtype of pathologically proven (biopsy or cytology), non-small cell lung cancer. The diagnosis may be established from biopsy or cytology obtained from the primary tumor and/ or from metastatic lymph nodes.

Minimal diameter of the primary tumor 4 cm, this to allow for boosting of sub-volumes.

UICC Stage T2-4, N0-3, M0 disease (TNM definition see appendix 2).

Only stage IB-II patients who are nog candidates for surgery are study candidates.

Renal: calculated creatinine clearance (CrCl) ≥ 45 ml/min based on the original weight based Cockcroft and Gault formula

For women: Must be surgically sterile, postmenopausal, or compliant with a highly reliable contraceptive method (failure rate <1%) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment and must not be breast-feeding.

For men: Must during chemotherapy take adequate contraceptive measures.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024829